Clinical laboratories are producing hundreds to thousands of patient sample test results per day. In case of reported test results outside a normal range or other irregularities, e.g. delta check violation, a requester maybe is starting appropriate actions, as for example a medical therapy. As this is a very sensitive area, laboratories have to store patient sample test results for a long time period in case of potential injuries or a brought in accusation. Such a time period can be up to 15 years.
Therefore, the corresponding laboratory is obliged to save besides the pure patient sample test result also the respective sample result context information to verify on demand how and under which conditions a certain patient sample test result has been generated, for example by a certain analytical unit. This complete information, i.e. the patient sample test result and the corresponding sample result context information, has to be recorded in order to show on demand that the corresponding laboratory is operating according to national regulations, international standards or internal quality SOP's.
Each reagent package which is used for a specific patient sample test is associated with a reagent lot number. Similarly, a control material used for a quality control measurement to check if a specific analytical unit is under control is associated with a quality control lot number. A calibrator material which is used for calibration purposes is also associated with a calibrator lot number.
In addition, a laboratory always has to provide a predefined reservoir of the different mentioned materials, namely of reagent packages, of quality control material and of calibrator material so that the laboratory is always capable to perform a specific test on a patient sample on demand. Within a laboratory environment it is very important in favor of security that those materials are always available in a sufficient predefined quantity.
The different lot numbers are included within the above mentioned sample result context information and is therefore directly associated with a corresponding sample test result.
Currently, the sample test results and the respective sample result context information is stored in different sources, as for example in a host system, an analytical unit or a paper printout. Furthermore, the reservoir of the different materials which has to be available on demand in case that a certain sample test has to be performed, is currently controlled separately.